APOTEX INC FDA Approval ANDA 078948

ANDA 078948

APOTEX INC

FDA Drug Application

Application #078948

Application Sponsors

ANDA 078948APOTEX INC

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 150MG BASE0IBANDRONATE SODIUMIBANDRONATE SODIUM

FDA Submissions

ORIG1AP2012-03-19
LABELING; LabelingSUPPL2AP2015-07-24STANDARD
LABELING; LabelingSUPPL5AP2015-07-24STANDARD
LABELING; LabelingSUPPL6AP2015-07-24STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL5Null15
SUPPL6Null7

TE Codes

001PrescriptionAB

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78948
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBANDRONATE SODIUM","submission":"IBANDRONATE SODIUM","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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